NIH DRUG DISCOVERY AND DEVELOPMENT CONSULTING SERVICES STATEMENT OF WORK A. BACKGROUND The National Institutes of Health (NIH) is the nation?s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people?s health and save lives. The National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. The NIH Blueprint for Neuroscience Research, a consortium of 8 NIH Institutes and Centers that support neuroscience research, established the Blueprint Neurotherapeutics Network (BPN) as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services are provided without cost to the PI through NIH contracts. The BPN currently has projects in the exploratory through preclinical safety stages. Some projects will proceed to the Investigational New Drug (IND) and clinical trial stages. Project continuation will depend on the achievement of project-specific milestones and portfolio management. New projects are reviewed twice per year and the highest scoring projects may be incorporated into the program. B. STATEMENT OF OBJECTIVE The NIH is seeking senior-level, industry-experienced drug discovery and development consultants with expertise in the following specific discipline to provide leadership and technical guidance on drug discovery and development projects in the BPN and possibly other NIH drug discovery and development projects and programs: ? Chemical Manufacturing and Controls / Pharmaceuticals C. SCOPE OF WORK The CMC/Pharmaceutics consultant hired under this requirement will not only make significant contributions to promising drug discovery and development projects that have been selected through a rigorous peer-review process, the consultant will also help shape an innovative, high-profile program that may serve as a model for future NIH drug discovery efforts. The contract consultant will be expected to provide feedback and guidance on projects and programs to the NIH and to BPN LDT members through conference calls and by email. The consultant may serve on an ad hoc basis or as member of LDTs. The consultant will be expected to offer input on project milestones, development strategy, study design, and data interpretation. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects and programs. D. General Requirements The consultant may serve on BPN LDTs, which require a regular time commitment of 3-10 hours per week, including meeting and preparation time. Each LDT meets for approximately 2 hours every 1-2 weeks by teleconference. The consultant may be asked to serve as a co-chair of LDTs. Serving as an LDT co-chair shall require the consultant to facilitate LDT discussions, work with an NIH project manager by email and telephone to maintain and communicate the overall project strategy to other LDT members, and advise the PI on the preparation of milestone reports. Co-chairs for LDTs are selected based on breadth of expertise and previous experience serving in a comparable role. A teleconference call with all consultants is held once or twice per month to discuss programmatic issues of broad interest. E. Specific Discipline Requirements The consultant will serve as a resource to LDT members for the regulatory requirements, processes, and logistics to conduct drug development activities for small molecule compounds from the preclinical stage through to the initial clinical stage. The consultant may be asked to provide strategic guidance for CMC regulatory activities necessary to enable preclinical drug product manufacturing, IND enabling studies, and clinical trials. The role of the CMC/Pharmaceutics consultant may include but is not limited to the following responsibilities and tasks: ? Lead CMC activities for compounds in development, in accordance with the US regulatory and the ICH guidelines. ? Provide expertise in drug substance manufacturing, analytical method development, and process development for small molecules. ? Provide pharmaceutical sciences leadership in chemical manufacturing, formulation, and product development for small molecules. ? Provide CMC guidance and strategy to LDTs, including identifying and assessing regulatory risks. ? Ensure the timely preparation, review and submission of CMC documents to regulatory authorities including FDA, EMA and other national authorities, to support the conduct of clinical trials and marketing applications. ? Ensure the compliance of CMC activities with applicable regulatory requirements. ? Evaluate manufacturing processes and changes, assess regulatory implications and support process implementation. ? Assist NIH with inspections and onsite visits with contract organizations. ? Maintain current knowledge of the relevant guidelines and regulations and determine applicability to activities. ? Provide expertise in dose form selection. ? Provide expertise in API development and related activities. F. QUALIFICATIONS F.1. General Experience The consultant must have extensive experience in managing or being a senior leader in drug discovery and development projects in the biopharmaceutical industry. Experience with drug discovery and development for nervous system conditions is required. Broad experience across the entire drug discovery and development process is especially desired. Consultants must be able to work in a virtual, cross-functional team environment and manage competing priorities. Consultants must have strong interpersonal skills, an attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy. Consultants must have experience working with multi-disciplinary teams at a senior level in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels. Experiences in team leadership, consulting, or service on strategic and advisory boards will be considered. F.2. Specific Discipline Experience The following educational and experience requirements are the minimum acceptable requirements. CMC/Pharmaceutics consultants should demonstrate expertise as follows: ? A Ph.D in science, chemistry degree preferred ? At least 10 years of CMC experience; small molecule experience required ? Previous experience in the preparation and submission of the CMC components of IND/CTA/NDA/MAAs ? Experience with drug discovery and development for nervous system conditions is required G. Level of Effort The NIH estimates that it will require the following labor hours as follows: CMC / Pharmaceuticals Consultant Year 1: Up to 800 hours Year 2: Up to 800 hours Year 3: Up to 800 hours Year 4: Up to 800 hours Year 5: Up to 800 hours H. Period of Performance Base Year ? May 2, 2017 through May 1, 2018 Option Period One ? May 2, 2018 through May 1, 2019 Option Period Two ? May 2, 2019 through May 1, 2020 Option Period Three ? May 2, 2020 through May 1, 2021 Option Period Four ? May 2, 2021 through May 1, 2022 J. Place of Performance Work on this contract will be performed at the Contractor?s site. BPN shall arrange entry of the Contractor into Government facilities as and when needed. K. Travel Consultants may be asked to travel for one-day site visits for the launch of BPN projects, Executive Oversight Committee meetings for the BPN, or other travel as requested. The consultant shall make his/her own travel arrangements. The Contracting Officer?s Representative (COR) may assist the consultant in identifying a hotel at an acceptable rate, if an overnight stay is required. The Contractor may bill up to 50% of travel hours to the Government, at the negotiated consulting rate. The Government shall reimburse all reasonable travel costs. Airplane tickets must be purchased from a US carrier, at the coach/economy rate. The Government shall reimburse hotel costs for up to two nights per site visit, as well as food and incidental expenses. The consultant shall make a good faith effort to select travel options that are the most time and cost-effective, given the available options. The consultant shall make a good faith effort to keep food and incidental costs within the typical government per diem rate for the region. L. Intellectual Property Consultants who contribute to the creation of new intellectual property will be named as inventors according to US or prevailing patent law. Accordingly, consultants must complete negotiations with the principal investigator?s institution regarding assignment of rights and royalties distribution prior to advising on any activities. The consultant shall provide copies of all intellectual property agreements to the NIH COR, for documentation purposes. M. Confidential Treatment of Sensitive Information The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government or by persons or entities applying to or accepted to the Blueprint Neurotherapeutics Network during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature. Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer. Contractor agrees that it will not use the Confidential Information for any purpose except as set forth within this SOW, unless such time as such Confidential Information becomes public information through the efforts of participants in the Blueprint Neurotherapeutics Network. N. Government Furnished Property No Government furnished property shall be provided. Project related data will be provided to the contractor for performance of work efforts. All data provided to consultant must be treated as confidential and not be disclosed to any third party. Project data will be collected and stored by NINDS. NINDS will provide data as needed to the consultant each time it requests service. The consultant may store data up to 12 months after initially receiving it, after that time the consultant should either delete the data files and sanitize the computer using NIST SP 800-88 (current revision) or if information is still needed contact the COR for approval to store data longer. P. Contract type A firm fixed price purchase order is anticipated. Q. Computer system requirements The contractor shall ensure that any computer system used in the course of this project shall include the following features: ? Computer used in this contract will be patched with most updated IT Security Patches. ? Any contractor computer used in this contract will have virus protection loaded and running with definition files that are updated on at least a daily basis. ? Hard drives and portable media used for this contract will be encrypted using the FIPS 140-2 standard. ? Contractors are required to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/ ? Consultant are required to sign the NIH non-disclosure agreement http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf ? Contractors are required to report any lost or stolen NIH data to the NINDS ISSO within one hour of knowing of the lost or theft even if the data is on a contractor furnished computer. ? Contractors are required to adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx ? Any computers used on the contract shall be assessed for vulnerabilities. ? Any computers used on the contract shall be backed up. ? Any computers used on this contract shall have auditing enabled such that if an incident occurred then that event could be reconstructed. ? Any computers that are uses in this contract must employ at a minimum user name and password authentication or if possible two factor authentication. ? Computer shall be password protected. All Password must meet the NIH standard: o Users must choose passwords that have at least eight characters o Choose a password with a combination of at least three of the following types of characters: ? capital letters ? lower case letters ? numeric characters ? special characters (!@#$%^&*()_+|~-=\`{}[]:;'<>?,./) R. Technical Proposal Preparation Offerors are requested to provide clear and convincing evidence of the offeror?s capability to fulfil the each Key Personnel requirement. Offerors are requested to provide the following: ? Current resume / CV ? A Technical proposal that: o Demonstrates that the Offeror clearly understands the role of BPN Consultant. o Demonstrates that the Offeror understands the Statement of Work. o Explains how the Offeror intends to comply with all requirements. ? In addition, the proposal should address each Key Personnel requirement listed in Section XXX and demonstrate how the Offeror meets the requirement. ? The Contractor shall provide a list of two (2) past performance references with knowledge of the contractor?s relevant skills and experience related to the requirements outlined in this Statement of Work. References shall include the following information: o Name of Organization o Description of Contractor?s responsibilities as they relate to this SOW o Contract Period of Performance o Contact Name and Title o Telephone Number o E-mail address S. Business Proposal Preparation Offerors are requested to complete and sign for SF 18 which is provided with this solicitation package. T. Technical Evaluation Criteria: Proposals will be scored based on the following three (3) technical evaluation criteria. T.1. Professional Experience in Drug Development ?40 points Offerors shall be evaluated based on hands-on and management experience in drug discovery and development projects, explicitly applicable to the corresponding discipline description listed in the statement of work. Evaluations shall be based on demonstrated expertise and experience in executing and managing drug development tasks, particularly for nervous system conditions. Broad experience across the entire drug discovery and development process is especially desired. Reviewers shall consider the Offerors? years of experience, breadth of expertise, and track record in drug development projects that go through to the clinic. Examples of measures of success include preparation of successful IND, CTA, NDA, and MA applications, as well as publications, patents, and work on drugs brought to market. In addition, experiences showing use of expertise to identify or anticipate problems early, overcome technical or regulatory difficulties, distill complex situations, or demonstrate strong risk-assessment ability to make wise use of limited resources shall be considered as signs of a strong track record in drug development. T.2. Education and Qualifications in Drug Development ? 20 points Offerors shall be evaluated for a combination of advanced education, board certifications, and other advanced expertise explicitly applicable to the corresponding discipline description listed in the statement of work. Evaluations shall be based on the Offerors? in-depth understanding of the drug development process, including regulatory procedures and guidelines where relevant, especially in small molecule drug development for CNS indications. T.3. Experience with Collaborative Teams ? 20 points Offerors shall be evaluated based on previous experience working with multi-disciplinary teams, especially teams with members from outside organizations and members at various management levels. Experiences such as team leadership, consulting, or service on strategic and advisory boards shall be considered as illustrations of collaborative work. Individual consultants and consulting companies that meet the Small Business size standard identified for this requirement are invited to apply to this solicitation. T.4. Past Performance ? 20 points The Contractor shall provide a list of two (2) past performance references with knowledge of the contractor?s relevant skills and experience related to the requirements outlined in this Statement of Work. References shall include the following information: o Name of Organization o Description of Contractor?s responsibilities as they relate to this SOW o Contract Period of Performance o Contact Name and Title o Telephone Number o E-mail address Total Possible Points - 100 The NIH may award multiple consulting contracts under this solicitation.